Kornimate/medical-research-clean huggingface dataset:
apbi versus ebrt therapy after breast conserving surgery for low-risk breast cancer

Conditions: Breast Cancer

Summary: to assess the role of interstitial brachytherapy alone compared to whole breast irradiation in a defined low-risk group of invasive breast cancer or ductal carcinoma in situ concerning local failure (all ipsilateral local recurrences) to affirm the hypothesis that local control rates in each arm are equivalent.

to assess the role of interstitial brachytherapy alone compared to whole breast irradiation in a defined low-risk group of invasive breast cancer or ductal carcinoma in situ concerning local failure (all ipsilateral local recurrences) to affirm the hypothesis that local control rates in each arm are equivalent.

Eligibility criteria:
inclusion criteria: * stage 0, i or ii breast cancer. * invasive ductal, papillary, mucinous, tubular, medullary or lobular carcinoma. * ductal carcinoma in situ (dcis) alone. * no lymph invasion (l0) and no hemangiosis (v0). * lesions of \> 3 cm diameter, histopathologically confirmed. * pn0/pnmi (a minimum of 6 nodes in specimen, or a negative sentinel node is acceptable); in the case of dcis alone axillary staging (e.g. sentinel lymph node biopsy) is optional. * m0. * clear resection margins at least 2 mm in any direction; by lobular histology or dcis histology only the resection margins must be clear at least 5 mm. * for dcis only: lesions must be classified as low or intermediate risk group (van nuys prognostic index \<8). * unifocal and unicentric dcis or breast cancer. * age \>= 40 years. * time interval from final definitive breast surgical procedure to the start of external beam therapy or to brachytherapy is less than 12 weeks (84 days). if patients receive chemotherapy the radiotherapy can be started before systemic treatment (within 12 weeks). the radiation therapy can be also given in the interval between the chemotherapy courses. it is also possible to start radiation therapy after chemotherapy is completed according local protocols as soon as possible within 4 weeks after chemotherapy. * signed study-specific consent form prior to randomization. exclusion criteria: * stage iii or iv breast cancer. * surgical margins that cannot be microscopically assessed. * extensive intraductal component (eic). * paget's disease or pathological skin involvement. * synchronous or previous breast cancer. * prior malignancy (\< 5 years prior to enrollment in study) except non-melanoma skin cancer or cervical carcinoma figo 0 and i if patient is continuously disease-free. * pregnant or lactating women. * collagen vascular disease. * the presence of congenital diseases with increased radiation sensitivity, for example ataxia telangiectatica or similar. * psychiatric disorders. * patient with breast deemed technically unsatisfactory for brachytherapy.

Keywords: accelerated partial breast irradiation multicatheter brachytherapy high dose rate brachytherapy pulsed dose rate brachytherapy
the charlson comorbidity index: predicting severity in emergency departments

Conditions: Emergency Medicine

Summary: objective: the charlson comorbidity index (cci) is a comorbidity scale used widely throughout the world. it uses patients' preoperative and intraoperative morbidity factors to evaluate morbidity and mortality risk. though the cci has widespread use, it has not been evaluated in patients attending at es, and its relationship with patient readmission has not been shown previously. in this study, we aimed to show whether there is a correlation between the cci value and the number of repeated admissions to emergency services and that the cci value can be used as a predicted factor for the serious patients. matherials and methods: this was a prospective observational cross-sectional study. age, gender, vital signs of the patients who agreed to participate in the study was recorded. numbers of emergency service applications in the last 6 months and cci score have been recorded.

this study showed that cci score can be used for identify serious patient in emergency service.

Eligibility criteria:
inclusion criteria: * admitted patients were told about the study, and those who agreed to participate were included exclusion criteria: * patients who did not wish to participate in the study * patients who were unable to work or who had problems with consciousness * patients with non-hospital cardiopulmonary arrest * patients who had previously participated in the study (readmitted patients) * patients who had accessed es for the same or a similar complaint within the last seven days * \< 18 years' old
ur+aims gout wearable skin uric acid monitor study

Conditions: Gout

Summary: 15 patients with gout \[10 patients no recent urate-lowering therapy (ult) and 5 patients on stable urate-lowering therapy (ult)\] will be invited to participate in a standardized meal at the ucla human nutrition center and a 7-day community follow-up for the measurement of uric acid (and other metabolites) using our uric acid and metabolite monitor system (ur+aims) skin patch.

first visit at the ucla human nutrition center: * patients will sign the informed consent, then answer some study questionnaires. * the uric acid and metabolite monitor system (ur+aims) skin patch and the study mobile device will be provided. * study nurse will start an iv for pre and post blood draws. * patients will be provided a standardized high-purine meal within 15 minutes. pre-blood is drawn right before the patients eat the meal, then post-blood will be drawn every 15 minutes for the first hour after completion of the meal, then every 30 minutes for the next 3 hours (total of 4 hours). * then patients will be sent home with the skin patch and study mobile device. community 7-day observation period: * patients will be asked to apply a study patch each morning before their first meal of the day. the patch should be removed at the end of the day and put under water. * the study device will monitor the patient's ua, glucose, heart rate, blood pressure, daily steps, and sleep. patients will be asked to enter before and after meal uric acid levels and may be asked to take a picture of their meals using the study mobile device.

Eligibility criteria:
inclusion criteria: 1. age \> 18 with diagnosis of gout (screening positive acr/eular gout classification criteria - see screening survey) and egfr \> 60 (within the last 12-months). 2. for the 10 patients with gout off urate-lowering therapy (ult) \[no allopurinol, febuxostat, or probenecid prescription within the last 6-months\] and serum urate (su) \> 7 mg/dl (within the last 12-months). 3. for the 5 patients with gout on urate-lowering therapy (ult) \[no dose change within the last 30 days\]. exclusion criteria: 1. contraindications to miosis, which include acute iritis, narrow-angle glaucoma 2. known hypersensitivity to pilocarpine hydrochloride 3. pupillary block glaucoma (ophthalmic solution) 4. subjects reporting any allergy to glue or latex or any allergy to food that will be provided in the study (sardines in extra virgin olive oil and sprite).
early integrated supportive care study for gastrointestinal cancer patients

Conditions: Cancer

Summary: currently at the bc cancer agency, oncologists decide when to refer a patient to the pain and symptom management/palliative care (psmpc) team, and their decisions are made subjectively and without standard guidelines/symptom assessment tools. patients are often referred late in their treatment. the psmpc team sees patients in their own clinic, separately from the oncologists, and do not often collaborate in a patient's care. early integration of palliative care into oncological care has been shown to improve quality of life and to prolong survival, as well as to reduce inappropriately aggressive oncological care at end of life, and reduce costs of care. we will test an early oncology-integrated palliative care model, with the aims of determining whether 1) the introduction of psmpc support at the time of diagnosis leads to better symptom management and quality of life of patients, 2) early integration of palliative care into medical oncology care reduces aggressiveness of cancer treatment near end of life, and 3) a fully integrated service delivery model is sustainable.

gastrointestinal (gi) medical oncologists will be assigned to intervention or control groups, according to whether or not they have clinics scheduled on 2 specific half days each week, to coincide with psmpc clinics. new patients attending the specified clinics under each oncologist will be automatically fall under whichever group their oncologist has been assigned. control patients will be those seen at clinics other than the 2 specified intervention clinics. patients will be approached for study participation in the waiting room of the gi clinic as they await their first oncology appointment. those who agree to participate will be asked to complete a symptom assessment questionnaire at baseline and once a month for 4 months. this timing is meant to coincide with their regularly scheduled follow up appointments with the gi oncologist. symptom scores from the completed assessment forms will be entered into a study database, created with the bc cancer agency ids of the study participants alongside an anonymized study id.

Eligibility criteria:
inclusion criteria: * diagnosed with a gastrointestinal (gi) cancer * have appointments in gi clinic during study days * able to complete a symptom assessment form on their own or with the help of a family member or interpreter exclusion criteria: * already receiving care from the pain and symptom management/palliative care team
clinical trial to evaluate the effect of a probiotic in acne

Conditions: Acne; Acne Vulgaris

Summary: a 12-week randomized, multicenter and double-blind, placebo-controlled study to evaluate the effect of a probiotic in the clinical and subjective evolution of acne in adolescent and adult patients.

acne is a chronic inflammatory disease of the skin that affects 85% of younger adults in westernized populations. acne pathophysiology is multifactorial and may include alterations of the pilosebaceous unit function, skin microbiota, hormone imbalance and gut microbiota. acne pathology shares features with inflammatory chronic conditions such as metabolic syndrome, obesity or diabetes. probiotics are live microorganisms that when administered in adequate amounts confer a health benefit for the host. probiotics are proposed for the treatment of inflammatory chronic conditions, including dermatological diseases as atopic dermatitis and psoriasis. however, the clinical evidence is limited. therefore, usefulness of probiotics for acne vulgaris treatment must be ascertained in humans. this randomized study aims to evaluate the effect of a probiotic on the treatment and clinical and subjective evolution of acne vulgaris.

Eligibility criteria:
inclusion criteria: * signature of informed consent by the patient (and their legal guardian in case of being under age). * age between 12 and 30 years-old. * agss (acne global severity scale) score: 2 or higher * patients who agree to follow the study's dietary recommendations. exclusion criteria: * contraindication of any of the components of the product under study. * topical or systemic use of antifungals and antibiotics in the previous 2 weeks. * consumption of probiotics in the previous 2 months. * use of systemic retinoids in the previous 6 months.

Keywords: probiotic acne microbiome microbiota symbiotic
incidence of melanoma and non-melanoma skin cancer in people with vitiligo

Conditions: Vitiligo; Melanoma (Skin); Nonmelanoma Skin Cancer; Squamous Cell Carcinoma; Basal Cell Carcinoma; Actinic Keratoses

Summary: this study examines melanoma and nonmelanoma skin cancer in people diagnosed with vitiligo compared to matched controls.

for the primary analysis, this study examines the risk of melanoma and nonmelanoma skin cancers: squamous cell carcinoma and basal cell carcinoma in people diagnosed with vitiligo. it also examines actinic keratoses. in secondary analysis, this study examines the prevalence of skin cancer in people diagnosed with vitiligo compared to matched controls. this study also examines whether the susceptibility to melanoma and nonmelanoma skin cancer may vary between different patient subgroups, e.g. ethnicity, those who undergo phototherapy or treatment with the new targeted biologic immunosuppressive therapies.

Eligibility criteria:
inclusion criteria: * all eligible adult patients (aged ≥ 18) registered with general practioner (gp) practices contributing data to opcrd between january 1, 2010 and december 31, 2020, were eligible for inclusion in the study. people diagnosed with vitiligo prior to the study period (prevalent vitiligo) and people newly diagnosed with vitiligo during the study period (incident vitiligo) are included as cases. exclusion criteria: * people actively registered with the gp practice at that date without a history of vitiligo require a minimum one-year registration with their gp practice.
the efficacy and safety of orosartan® versus codiovan® in patients with essential hypertension uncontrolled with monotherapy

Conditions: Hypertension

Summary: a multi-center, randomized, double-blind, phase iv clinical trial to compare the efficacy and safety of orosartan® tablet 5/160mg versus codiovan® tablet 160/12.5mg in patients with essential hypertension uncontrolled with valsartan 160mg monotherapy


Eligibility criteria:
inclusion criteria: * 19 aged or over * a patient who was diagnosed with essential hypertension at screening(visit 1) * a patient understood objective of this clinical trial and gave their written informed consent voluntarily exclusion criteria: * a patient with severe hypertension(mssbp≥200mmhg or msdbp≥120mmhg) at visit 1 * a subject with difference(as mssbp≥20mmhg or msdbp≥10mmhg) in blood pressure between right and left arm at screening evaluation * medical history or evidence of a secondary form of hypertension * a subject with history of hypersensitivity to ccb(calcium channel blocker), arb(angiotensin ii receptor blocker) or sulfonamide
fatigue and sleep in patients with covid-19

Conditions: Covid19

Summary: recent studies show that patients who have contracted covid-19 retain very significant fatigue after resolving the infectious episode. this fatigue may be explained by low-grade inflammation. there is more data for patients with covid-19 who have been hospitalized than for non-hospitalized patients with milder forms. however, covid-19 related fatigue would not only affect elderly people with severe cardiopulmonary consequences but also young subjects without severities. this notion is not very widespread and to date, covid contracted by young subjects is considered to have very few consequences on their health. it is also known that the prevalence of sleep debt is significant in the general population and particularly in young people, and it is also known that sleep deprivation increases low-grade inflammation and facilitates the risk of viral contamination. the association between sleep deprivation, drowsiness and possibly low-grade inflammation raise questions about the mechanisms of fatigue in the general population. investigators are also entitled to wonder to what extent the chronic sleep debt suffered by the french population can explain an increased risk of contamination by covid 19 but also significant residual fatigue after covid infection. bordeaux university hospital screens 2,000 subjects per day at risk of being infected by covid, it would be very interesting to measure, in a population of young adults aged 18-45 years, frequently exposed to a sleep debt, sleep hygiene (bedtime and wake-up times, sleep and wake-up schedules, and overall sleep satisfaction), average sleep duration, level of fatigue and drowsiness and to compare these thresholds between subjects with or without covid 19 according to nasopharyngeal pcr.


Eligibility criteria:
inclusion criteria: * patient or healthcare professional going to screening center to perform a pcr test for covid-19 * between 18 and 45 years old * symptomatic or not * whether or not covid-19 contact-case * accepting to participate to the research * informed and having expressly transmitted their non-opposition to participate in the study exclusion criteria: * participants who do not speak french or who cannot read or write * patients who do not have contact information for recall * refusal to participate in the study. * majors under guardianship or curatorship.

Keywords: covid-19 fatigue
comparison of a multifocal contact lens to a traditional multifocal contact lens

Conditions: Presbyopia

Summary: the purpose of the trial is to compare the performance of two multifocal contact lens systems/products in established presbyopic subjects.


Eligibility criteria:
inclusion criteria: * be at least 35 years of age. * best-corrected visual acuity of at least 20/40 in each eye. * spectacle add from +1.50d and +2.50d (inclusive). * able to be fit in available study sphere powers (plano to -4.00d). * currently wearing soft contact lenses at least 5 days a week. * other protocol inclusion / exclusion criteria may apply. exclusion criteria: * requires concurrent ocular medication. * eye injury or surgery within twelve weeks immediately prior to enrollment. * currently enrolled in an ophthalmic clinical trial. * evidence of systemic or ocular abnormality, infection or disease likely to affect successful wear of contact lenses or use of their accessory solutions. * previous refractive surgery. * astigmatism \> 1.00d. * currently wearing proclear multifocal, frequency 55 multifocal or biomedics ep contact lenses. * other protocol inclusion / exclusion criteria may apply.
german spondyloarthritis inception cohort

Conditions: Ankylosing Spondylitis (AS) / Radiographic Axial SpA (r-axSpA); Non-radiographic Axial Spondyloarthritis (Nr-axSpA); Axial Psoriatic Arthritis (axPsA); Acute Anterior Uveitis (AAU); Crohn Disease (CD); Ulcerative Colitis (UC)

Summary: the german spondyloarthritis inception cohort (gespic) was started 2000 as a prospective, longitudinal, multicentre, nationwide study in germany on patients with early spa including ankylosing spondylitis (as, also known as radiographic axial spondyloarthritis) and non-radiographic axial spa. the objectives of gespic are to learn about the course of spa during the very early stage of the disease, to appropriately assess the outcome including radiographic progression of patients after several years of follow-up, to identify outcome predictors, to assess quality of life, function, and costs (direct and indirect costs). gespic has been recently expanded to recruit patients with other forms of spa / conditions associated with spa: acute anterior uveitis, crohn's disease as well as with psoriasis / axial psoriatic arthritis.


Eligibility criteria:
main inclusion criteria: * patients with definite diagnosis of axial spondyloarthritis or juvenile spondyloarthritis. * patients with definite diagnosis of crohn's disease. * patients with definite diagnosis of acute anterior uveitis. * patients with definite diagnosis of psoriatic arthritis with axial involvement.
influence of coffeeberry ingestion on soccer skill performance

Conditions: Skill Performance; Soccer Performance; Coffeeberry Effects

Summary: the study of soccer skill performance has 3 objectives. objective 1 is to compare effects of coffeeberry (300mg) and placebo ingestion on dribbling speed and precision and passing and shooting speed and accuracy compared to placebo. 30 subjects will be assessed before dosing, after a 1 hr resting absorption period, and after simulated soccer match play. of these 30, 20 subjects will proceed to objective 2 (45 minutes of intense simulated soccer match play) and objective 3 (repeated sprint activity continued until volitional fatigue).


Eligibility criteria:
inclusion criteria: * provide valid informed consent prior to any study procedure * male soccer players age 16 to 28 years * 5-year soccer playing experience * 1-year regularly soccer training * free of injuries * willing to avoid alcohol in the 48-h period prior to main trials. * willing to avoid caffeine, caffeinated and decaffeinated products, apples, and, berries/cherries for 24-h prior to main trials * willing to record food intake over the 48-h period prior to the first trial and replicate for second trial * willing to abstain from strenuous physical activity for 24-h before all visits exclusion criteria: * smoking * cardiovascular diseases * diabetes or other metabolic disease * presence of injuries * major illnesses or surgery in prior 90 days * participation in another clinical trial in the past month

Keywords: coffeeberry caffeine polyphenols chlorogenic acid exercise soccer skill performance
predictive model on the effect of lifestyles in the management of t2d

Conditions: Type 2 Diabetes

Summary: this study aims to produce new evidence on the positive effects of physical activity and certain individual lifestyles in the control of type 2 diabetic disease. the goal is to build and evaluate the effectiveness of a new parsimonious risk prediction model based on the use of classical variables (blood exams), already used in other models for predicting the risk related to the disease, together with measures obtained from the use of wearable devices (steps count, sleep hours, heart rate).

scientific literature has shown that the use of wearable devices can improve the control of type 2 diabetes mellitus. the aim of the study is to develop a statistical model for the control of type 2 diabetes mellitus (dmt2) based on the use of "conventional" clinical parameters and the use of "unconventional" data from wearable devices. the medical outcome variable that will be used to measure diabetes control and model performance will be the glycated hemoglobin (hba1c). the participant will receive a samsung smartwatch (galaxy watch 3) and a samsung smartphone (a51), (the latter only in case the participant is not in possession of a compatible smartphone) which he/she must wear during his daily activities and also during the night to measure daily activity, sleep hours and heart rate. casa sollievo della sofferenza hospital previoulsy developted the enforce calculator, an inexpensive and parsimonious prediction model of 2-year all cause mortality in real life patients with t2d. in this study the investigators aim to elaborate a standardized validated risk scores similar to what has been done for enforce.

Eligibility criteria:
inclusion criteria: * age ≥ 55 years old * affected by type 2 diabetes and monitored by casa sollievo della sofferenza hospital * basic skills in using a smartphone and its apps * available to use the device and its applications * ability to understand the informed consent exclusion criteria: * inability to understand the informed consent * low life expectancy * type 1 diabetes * secondary diabetes

Keywords: t2d consumer devices smartwatch artificial intelligence